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Result Summaries: fosamprenavir

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Study ID
   Phase    Title Summary (Download)
100290 phase 3 A phase IIIB/IV, open-label, multi-center trial to evaluate the safety, tolerability, and efficiency of HIV-1 infected subjects switching their current protease-inhibitor therapies for a fosamprenavir therapy over 48 weeks (0 citation(s)) Click here to download result summary.
100732 phase 3 A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks (2 citation(s)) Click here to download result summary.
100732_144weeks Phase 3 A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naiv (1 citation(s)) Click here to download result summary.
102027 Phase 3 Expanded access program for fosamprenavir (FPV, GW433908) in HIV infected subjects not responding or intolerant to the previous antiretroviral treatments. (0 citation(s)) Click here to download result summary.
104501 Phase 1 Pharmacokinetic study of LEXIVA® (fosamprenavir calcium hydrate) tablet in healthy Japanese male subjects. (0 citation(s)) Click here to download result summary.
107484 Phase 1 A Phase I, Randomized, Open Label, Four Arm, Two Period, Two 2X2, Crossover, Drug Interaction Study to Assess Steady-State Plasma Amprenavir and Phenytoin Pharmacokinetics following Administraction of Fosamprenavir 700mg BID + Ritonavir 100mg BID + Phenytoin 300mg QD, Fosamprenavir 700mg BID + R ... (0 citation(s)) Click here to download result summary.
111945_4 N/A Studies using DAD - HIV and Hepatitis Coinfection Initiative (5 citation(s)) Click here to download result summary.
111949 n\a HI FPV study: Using observational cohorts to monitor safety of fosamprenavir in patients with mild/moderate hepatic impairment (0 citation(s)) Click here to download result summary.
111950_7 n\a Fractures over time stratified by HIV infection and Antiretroviral Therapy (ART) exposure (0 citation(s)) Click here to download result summary.
112334 Phase 2 Drug Use Investigation for Lexiva tablet (HRD Cooperative Investigation) (0 citation(s)) Click here to download result summary.
112346 Phase 2 Special Drug Use Investigation for Lexiva tablet (Pregnancy) (HRD Cooperative Investigation) (0 citation(s)) Click here to download result summary.
112418 Phase 4 Nadis Retrospective data analysis (1 citation(s))
112872_7 n\a HIV treatment and CVD events - Ingenix. Retrospective Database Analysis of Patients with Human Immunodeficiency Virus (HIV) Treatment and Cardiovascular Disease (CVD) Events (0 citation(s)) Click here to download result summary.
112874_4 N/A Incidence and Risk Factors for New-onset Diabetes in HIV-infected Patients. The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study (1 citation(s)) Click here to download result summary.
112877_2 N/A Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration (5 citation(s)) Click here to download result summary.
112878_4 N/A Diabetes Mellitus, Preexisting Coronary Heart Disease, and the Risk of Subsequent Coronary Heart Disease Events in Patients Infected With Human Immunodeficiency Virus (2 citation(s)) Click here to download result summary.
112880 N/A An observational multi-cohort study on the use of Fosamprenavir-Ritonavir among HIV-infected children and adolescents in Europe (1 citation(s))
112884_4 N/A The metabolic syndrome in the DAD Study (2 citation(s)) Click here to download result summary.
112885_7 N/A Antiretroviral Pregnancy Registry (APR)-Risk of birth defects associated with exposure to GSK HIV drugs during pregnancy (1 citation(s)) Click here to download result summary.
112885_8 N/A Antiretroviral Pregnancy Registry (APR)-Risk of birth defects associated with exposure to GSK HIV drugs during pregnancy (0 citation(s)) Click here to download result summary.
112886_4 N/A Changes over time in risk factors for cardiovascular disease and use of Lipid-Lowering drugs in HIV-infected individuals and impact on myocardial infarction. (0 citation(s)) Click here to download result summary.
112887_7 N/A Studies using DAD - Effects of different interventions to improve ART-associated dyslipidemia (1 citation(s)) Click here to download result summary.
112889_4 N/A HIV-induced immunodeficiency and mortality from AIDS-defining and non-AIDS-defining malignancies (0 citation(s)) Click here to download result summary.
112952_1 N/A Demographic and clinical differences in patients receiving PI and NNRTI regimens, & Factors associated with hepatic outcomes (1 citation(s)) Click here to download result summary.
113039_7 N/A Studies using DAD - Lipid profiles in HIV-infected patients receiving combination antiretroviral therapy: Are different antiretroviral drugs associated with different lipid profiles? (1 citation(s)) Click here to download result summary.
113150_1 N/A Prevalence of Known Mutations Associated with HIV Resistance to Protease Inhibitors (PI) among Subjects Failing a First Line Regimen Containing PIs and Subsequent Regimens Containing PIs (0 citation(s)) Click here to download result summary.
113152 N/ Studies in Royal free – Thyroid dysfunction in HIV positive patients. (1 citation(s)) Click here to download result summary.
113154_4 N/A Predictors of hypertension and changes of blood pressure in HIV-infected patients (2 citation(s)) Click here to download result summary.
113156_7 N/A Studies using the VA - Studies done under the Oversight Committee for the Evaluation of the metabolic complications of HAART (2 citation(s)) Click here to download result summary.
113329_7 n\a Lactic acid levels in children pre- and perinatally treated with antiretrovirals to prevent HIV transmission (Giaquinto; Hyperlactatemia in infants with in utero exposure to ZDV/3TC ) (2 citation(s)) Click here to download result summary.
APV 20003 Phase 2 See Detailed Description (0 citation(s)) Click here to download result summary.
APV10006 Phase 1 A Pivotal, Phase I, Single-dose, Open-label, Randomized, Two-way Crossover Study to Assess the Bioequivalence of 2x700mg GW433908 Oral Film-coated Tablets to 3x465mg GW433908 Oral Film-coated Tablets in Healthy Adult Subjects (1 citation(s)) Click here to download result summary.
APV10007 Phase 1 A Phase I, Single-dose, Open-label, Randomized, Three-way, Balanced, Crossover Study to Assess the Effect of MAALOX TC and ZANTAC on Plasma Amprenavir Pharmacokinetics Following Administration of a 1400mg Single Dose of GW433908 (1 citation(s)) Click here to download result summary.
APV10008 Phase 1 A Phase I, Single-dose, Open-label, Randomized, Four-period, Balanced Crossover Study to Assess the Relative Bioavailability of the GW433908 Oral Suspension Relative to the GW433908 Oral Film-coated 700mg Tablet and to Assess the Effects of Food on Amprenavir Pharmacokinetics Following Administr ... (2 citation(s)) Click here to download result summary.
APV10009 Phase 1 A Phase I, Randomized Study to Assess the Effect of Efavirenz 600mg QD on Steady-State Plasma Total Amprenavir and Ritonavir PK Following Coadministration with GW433908 1395mg QD + Ritonavir 200mg QD or GW433908 1395mg QD + Ritonavir 300mg QD for 14 Days as Compared to GW433908 1395mg QD + Riton ... (2 citation(s)) Click here to download result summary.
APV10010 Phase 1 A Phase I, Randomized Study to Assess the Effect of Efavirenz 600mg QD on Steady-State Plasma Total Amprenavir Pharmacokinetics Following Co-administration with GW433908 700mg BID + Ritonavir 100mg BID or GW433908 700mg BID + Ritonavir 200mg BID for 14 Days as Compared to GW433908 700mg BID + RT ... (2 citation(s)) Click here to download result summary.
APV10011 Phase 1 A Phase I, Open, Randomized, Balanced, Incomplete Crossover Drug-Drug Interaction Study to Assess the Steady-State Plasma Amprenavir and Lopinavir Pharmacokinetics following Administration of Lopinavir 533mg/Ritonavir 133mg BID + GW433908 1400mg BID, GW433908 700mg BID + Ritonavir 100mg BID, or… (1 citation(s)) Click here to download result summary.
APV10012 Phase 1 A Phase I, Open, Randomized, Balanced, Incomplete Crossover Drug-Drug Interaction Study to Assess the Steady-State Plasma Amprenavir and Lopinavir Pharmacokinetics following Administration of Lopinavir 400mg/Ritonavir 100mg BID + GW433908 700mg BID + Ritonavir 100mg BID, GW433908 700mg BID + Rit ... (1 citation(s)) Click here to download result summary.
APV10013 Phase 1 A Phase I, Randomized, Open Label, Three Period, Single Sequence, Steady State, Drug-Drug Interaction Study between Atorvastatin 10mg QD and GW433908 1400mg BID and between Atorvastatin 10mg QD and GW433908 700mg BID + Ritonavir 100mg BID in Healthy Adult Subjects (2 citation(s)) Click here to download result summary.
APV10014 Phase 1 A Phase I, Open Label, Single Arm, Three Period, Drug-Drug Interaction Study to Assess the Steady-State Plasma Amprenavir and Nevirapine Pharmacokinetics Following Administration of GW433908 1400mg BID + Nevirapine 200mg BID for 14 days and GW433908 700 mg BID + Nevirapine 200mg BID + Ritonavir ... (1 citation(s)) Click here to download result summary.
APV10015 Phase 1 A Pivotal, Phase I, Single-dose, Open-label, Randomized, Three Period, Balanced Crossover Study to Assess the Bioequivalence of GW433908 Oral Film-coated 700mg Tablet Formulations in Healthy Adult Subjects (0 citation(s)) Click here to download result summary.
APV10016 Phase 1 A Pivotal, Phase I, Single-dose, Open-label, Randomized, Four Period, Balanced Crossover Study to Assess the Relative Bioavailability of the GW433908 Oral Suspension and Oral Film-coated 700mg Tablet Formulations and the Effect of Food on the Bioavailability of These Formulations in Healthy Adul ... (1 citation(s)) Click here to download result summary.
APV10017 phase 1 A Phase I, Parallel, Open-label, Multicenter, Two-Week, Repeat-dose Study Evaluating Plasma Amprenavir Pharmacokinetics in HIV-1-infected Adult Subjects with Mild, Moderate or Severe Hepatic Impairment Receiving Fosamprenavir + Ritonavir Compared to Matched Control Subjects with Normal Hepatic Function (1 citation(s)) Click here to download result summary.
APV10018 Phase 1 A Phase I, Randomized, Open Label, Four Arm, Two Period, Two 2x2, Crossover, Drug Interaction Study to Assess Steady-State Plasma Amprenavir and Atazanavir Pharmacokinetics following Administration of Fosamprenavir 700mg BID + Ritonovir 100mg BID + Atazanavir 300mg QD, Fosamprenavir 700mg BID + ... (0 citation(s)) Click here to download result summary.
APV10020 Phase 1 A Phase I, Open Label, Two Period, Single-Sequence, Drug-Drug Interaction Study Comparing Steady-State Plasma Ethinyl Estradiol and Norethisterone Pharmacokinetics following Administration of Brevinor for 21 Days with and without Fosamprenavir 700 mg Twice Daily (BID) and Ritonavir 100 mg BID fo ... (0 citation(s)) Click here to download result summary.
APV10021 Phase 1 A Pivotal, Phase I, Single-dose, Open-label, Randomized, Two-Period, Balanced Crossover Study to Assess the Bioequivalence of GW433908 Oral Film-coated 700mg Tablets in Healthy Adult Subjects (1 citation(s)) Click here to download result summary.
APV10022 Phase 1 A Phase I, Randomized, Open Label, Two-Period, Four-Arm, Balanced Cross-over, Steady-state, Drug Interaction Study between Ritonavir 100mg BID and FPV 700mg BID and between Ritonavir 100mg BID and AGENERASE† 600mg BID in Healthy Adult Subjects (1 citation(s)) Click here to download result summary.
APV10023 Phase 1 A Pivotal, Phase I, Open-label, Randomized, Four-Period, Single and Multiple Dose, Crossover Study to Assess the Bioequivalence of Two GW433908 700mg Oral Film-coated Tablet Variants Following Administration of Single 1400mg Doses and Following Administration of 1400mg BID for 14 Days… (1 citation(s)) Click here to download result summary.
APV10024 Phase 1 A Pivotal, Phase I, Open-label, Randomized, Four-Period, Two-Part, Crossover Study to Assess the Relative Bioavailability of the Fosamprenavir 50mg/mL Oral Suspension and 700mg Oral Film-coated Tablet Formulations Following Administration of Single 1400mg Doses and Following Administration of 14 ... (0 citation(s)) Click here to download result summary.
APV10025 Phase 1 A Phase I, Randomized, Open Label, Two Period, Two Sequence, Drug-Drug Interaction Study Comparing Steady-State Plasma Rifabutin Pharmacokinetics following Coadministration of Fosamprenavir 700mg + Ritonavir 100mg Twice Daily (BID) and Rifabutin 150mg Every Other Day (QOD) and following Administ ... (1 citation(s)) Click here to download result summary.
APV10026 Phase 1 A Phase I, Open-Label, Single-Sequence, Drug-Drug Interaction Study Comparing Ketoconazole and Amprenavir Pharmacokinetics Following Administration of Ketoconazole 200 mg QD for Four Days, Fosamprenavir 700mg BID + Ritonavir 100mg BID for Ten Days, and Ketoconazole 200 mg QD + Fosamprenavir 700m ... (0 citation(s)) Click here to download result summary.
APV10028 Phase 1 A Phase I, Open, Randomized, Balanced, Three-Period, Crossover, Steady-State, Pharmacokinetic Study Comparing GW433908 1400mg BID + RTV 100mg BID, GW433908 1400mg BID + RTV 200mg BID, and GW433908 700mg BID + RTV 100mg BID Regimens in Healthy Adult Subjects (3 citation(s)) Click here to download result summary.
APV10029 Phase 1 A Phase I, Open-label, Randomized, Two-Period, Balanced Crossover, Study to Compare Steady-State Plasma Amprenavir Pharmacokinetics following administration of Two GW433908 Tablet Variants, Each administered as 1400mg QD in Combination with Ritonavir 200mg QD in Healthy Adult Subjects (0 citation(s)) Click here to download result summary.
APV10031 Phase 1 A Phase I, Randomized, Open Label, Two Arm, Three Period, Drug-Drug Interaction Study Comparing Steady-State Plasma Amprenavir and Esomeprazole Pharmacokinetics following Coadministration of GW433908 1400mg BID and Esomeprazole 20mg QD and following Coadministration of GW433908 700mg BID + RTV 1 ... (1 citation(s)) Click here to download result summary.
APV102002 phase 3 A Phase III, Randomized, Controlled, Open-label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-boosted HIV-1 Protease Inhibitor regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-infected Adults Experiencing Virological Failure (1 citation(s)) Click here to download result summary.
APV109141 phase 3 Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects. (3 citation(s)) Click here to download result summary.
APV20001 Phase 2 Open-Label Phase Report of: A Randomized, Multicenter, Partially Double-Blinded, Repeat Dose, Cross-Over Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Effect of Two Doses of FPV Compared with AGENERASE(1200mg BID) when Given for 28 Days to Subjects Infected with HIV-1 (3 citation(s)) Click here to download result summary.
APV20002 phase 2 A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced pediatric subjects aged 4 weeks to <2 years. (1 citation(s)) Click here to download result summary.
APV29005 phase 2 A 48 Week, Phase II, Non-Comparative, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir BID when Administered to HIV-1 infected, PI-Naïve and Experienced, Pediatric Subjects, 2 to 18 Years Old and of GW433908 BID Administered to PI-Naïve, Pediatric Subjects 2 to < 6 Years Old (3 citation(s)) Click here to download result summary.
APV30001 Phase 3 A Phase III, Randomized, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety and Tolerability of GW433908 (1400mg BID) and Nelfinavir (1250mg BID) Over 48 Weeks in Antiretroviral Therapy-Naïve HIV-1 Infected Adults (2 citation(s)) Click here to download result summary.
APV30002 Phase 3 A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination with Abacavir and Lamivudine BID for 48 Weeks in Antiretroviral Therapy Naïve HIV-1 Infected Subjects (5 citation(s)) Click here to download result summary.
APV30003 Phase 3 A Phase III, Randomized, Multicenter, Parallel Group, Open-label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/ritonavir (700mg/100mg twice daily or 1400mg/200mg once daily) versus lopinavir/ritonavir (400mg/100mg twice daily) for 48 Weeks in Protease Inh ... (3 citation(s)) Click here to download result summary.
APV30005 phase 3 An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects (1 citation(s)) Click here to download result summary.
APV30007 phase 3 A 24 week Phase IIIb/IV single arm open label observational study to explore the efficacy of protease inhibitors given in combination with reverse transcriptase inhibitors to HIV-1 infected subjects with protease mutations selected during therapy with GW433908 containing antiretroviral therapy (0 citation(s)) Click here to download result summary.
APV40003 Phase 4 Safety and efficacy of GW433908 in antiretroviral combination therapy in patients with HIV infection (0 citation(s)) Click here to download result summary.
APV40004 Phase 4 Expanded access programme of Fosamprenavir (GW433908) /ritonavir for patients infected by HIV. (0 citation(s)) Click here to download result summary.
APV40005 phase 4 An open-label phase III study to provide access to fosamprenavir and to assess the long term safety and tolerability of fosamprenavir containing regimens in HIV Infected patients with limited treatment options (0 citation(s)) Click here to download result summary.
APV40006 Phase 4 GW433908 Open Label Study for Subjects with HIV who are Treatment Experienced, on a Failing Regimen or Intolerant to Current Therapy and Sensitive to GW433908 (0 citation(s)) Click here to download result summary.
APVF3002 Phase 3 Multicentre, open label, pilot study to evaluate genotypic sensitivity score of fosamprenavir (700mg) in combination with ritonavir (100mg) twice daily, in human immunodeficiency virus (HIV) infected patients with virological escape after first line treatment with a protease inhibitor (PI). (0 citation(s)) Click here to download result summary.
APVF3031 Phase 3 Multicentre, randomized, comparative, open, pilot study to assess efficacy and safety of a treatment with two protease inhibitors (GW433908 + Indinavir [IDV, Crixivan]) boosted by ritonavir in combination with nucleoside reverse transcriptase inhibitor (NRTI) in experienced HIV-1 infected subjects. (0 citation(s)) Click here to download result summary.
APVF3032 Phase 3 Efficacy and pharmacologic evaluation at week 4 of fosamprenavir/ritonavir BID in HIV, pretreated patients switching from amprenavir/ritonavir with controlled plasma viremia. (0 citation(s)) Click here to download result summary.
ESS40001 Phase 2 A Phase II, Open-Label, Randomized Study to Compare the Efficacy and Safety of EPIVIR/ZIAGEN/Zerit (3TC/ABC/d4T) Versus EPIVIR/ZIAGEN/Sustiva (3TC/ABC/EFV) Versus EPIVIR/ZIAGEN/GW433908/Norvir (3TC/ABC/908/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who are Antiretroviral Thera ... (1 citation(s)) Click here to download result summary.
LEX106430 phase 3 A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD) (1 citation(s)) Click here to download result summary.
NN210010 Phase 1 A Phase I, Open Label, Randomized, Three Cohort Study to Investigate the Potential Pharmacokinetic Interaction, Safety and Tolerability of GW695634G 400mg q12h and Three Ritonavir-boosted HIV-1 Protease Inhibitors (Atazanavir, Fosamprenavir and Lopinavir) Following Oral Administration to Healthy ... (0 citation(s)) Click here to download result summary.